Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

NCT01373294 | Completed Phase 2 Results

• 2 other identifiers: MCC-16295RV-BLD-PI-0330
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to:

• find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG);
• evaluate the safety and tolerability of the combination of lenalidomide and BCG;
• compare the cancer progression of participants taking lenalidomide and BCG versus participants taking only BCG

Conditions

Bladder Cancer

Keywords

non-muscle-invasive; transitional cell; oral lenalidomide; intravesical

Outcome Measures

Primary Outcomes (1)

• Arm A: Progression Free Survival (PFS)

  The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison

  1 year

Secondary Outcomes (1)

• Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Duration of study treatment and follow-up - average of 12 months

Other Outcomes (2)

• Effect of Addition of Revlimid on Cytokines

  Duration of study treatment and follow-up - average of 12 months

• Comparison of the Correlative Assay

  1 year post disease response

Study Arms (2)

A: Combination Arm

EXPERIMENTAL

Bacille Calmette-Guerrin (BCG) and lenalidomide. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide)

Drug: Bacille Calmette-Guerrin (BCG); Drug: Lenalidomide

B: Control Arm

ACTIVE COMPARATOR

Bacille Calmette-Guerrin (BCG) only. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group was not eligible to receive the combination of BCG + lenalidomide.

Drug: Bacille Calmette-Guerrin (BCG)

Interventions

Bacille Calmette-Guerrin (BCG) DRUG

Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks.

Also known as: BCG Vaccine

A: Combination Arm; B: Control Arm

Lenalidomide DRUG

Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide.

Also known as: Revlimid®

A: Combination Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form
• Able to adhere to the study visit schedule and other protocol requirements
• Ta high grade, T1 high grade or Tis transitional cell bladder cancer, s/p transurethral resection of bladder tumor (TURBT) with no remaining resectable disease
• Adequate cardio-pulmonary function (\</= Class II ) as defined by New York Heart Association Classification, at the time of screening, and no history of myocardial infarction or heart failure within 6 months of start
• Laboratory test results within these ranges:
• Absolute neutrophil count ≥ 1500/mm³
• Platelet count ≥ 75,000
• Serum creatinine for which computed creatinine clearance is ≥ 30 ml/min, or directly measured creatinine clearance ≥ 30 ml/min
• Total bilirubin ≤ 1.5 mg/dL
• Aspartate transaminase (AST) \[serum glutamic oxaloacetic transaminase (SGOT)\] and Alanine transaminase (ALT) \[serum glutamate pyruvic transaminase (SGPT)\] ≤ 2 x upper limit of normal (ULN)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
• Prior BCG treatment for non-muscle invasive transitional cell carcinoma (TCC) last administered \< 2 years for Ta high-grade, T1 high grade, Cis, or combination thereof
• Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
• Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from providing informed consent
• Pregnant or breast feeding (lactating females must agree not to breast feed while taking lenalidomide)
• Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Use of any other experimental drug or therapy within 28 days of baseline
• Known hypersensitivity to thalidomide
• Known hypersensitivity to BCG or tuberculosis vaccination
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• Any prior use of lenalidomide
• Concurrent use of other anti-cancer agents or treatments.
• Known presence of autoimmune disease or immune deficit or chronic disease such as HIV, infectious hepatitis (type B or C), or tuberculosis
• T2+, or N1+, or M+ disease
• Ta or T1 low grade disease only
• Concurrent use of chronic oral steroids, for any indication
• Recent history of deep venous thrombosis currently receiving anticoagulation therapy, with the clot event being in the last 6 months
• Diagnosis of any prior malignancies for the last 5 years with exception of definitively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Celgene Corporation: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG Vaccine; Lenalidomide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study closed to accrual early, due to slow accrual. Too few participants were enrolled into Arm B to conduct the planned per arm comparisons.

Results Point of Contact

• Title: Dr. Mayer Fishman
• Organization: H. Lee Moffitt Cancer Center and Research Institute

mayer.fishman@moffitt.org

813-745-8311

Study Officials

• Mayer Fishman, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 14, 2011
• Study Start: November 30, 2011
• Primary Completion: January 9, 2015
• Study Completion: December 10, 2018
• Last Updated: August 6, 2019
• Results First Posted: May 12, 2016

Record last verified: 2019-08

Locations

US (1)